Frontiers in Medical Technology | Regulatory Affairs

Review

Accepted on 08 Sep 2025

Enhancing the digital adoption in Healthcare Built Environments: A Framework for a Therapeutic User-Based Wayfinding System

in Regulatory Affairs

Yasmin Garcia-Sterling
Karim Farghaly
Michael Pitt

Frontiers in Medical Technology

doi 10.3389/fmedt.2025.1323446

147 views

Perspective

Accepted on 29 Aug 2025

A hybrid, iterative approach to support development of fit-forpurpose sensor-derived measures

in Regulatory Affairs

Belén Rubio Ballester
Matthew Reaney
Christina Mack
Salma Ajraoui

Frontiers in Medical Technology

doi 10.3389/fmedt.2025.1567537

224 views

Review

Published on 15 May 2025

Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union

in Regulatory Affairs

Tanvi Gupte
Tushar Nitave
Jogarao Gobburu

Frontiers in Medical Technology

doi 10.3389/fmedt.2025.1586070

6,079 views

Mini Review

Published on 09 May 2025

Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law

in Regulatory Affairs

Johannes Freise

Frontiers in Medical Technology

doi 10.3389/fmedt.2025.1548927

2,766 views

Policy Brief

Published on 03 Feb 2025

Survey of Notified Bodies reveals very limited use of conditional certification for high-risk medical devices

in Regulatory Affairs

A. Dobrzynska
J. C. Rejon-Parrilla
D. Epstein
J. Aranda-López
A. G. Fraser
J. A. Blasco-Amaro

Frontiers in Medical Technology

doi 10.3389/fmedt.2025.1504294

2,170 views

Review

Published on 16 Dec 2024

US regulatory compliance for medical combination products: an overview

in Regulatory Affairs

Manav V. Singh
Prafulla Apshingekar
Sanyam Gandhi
Om V. Singh

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1486318

2,610 views
2 citations

Mini Review

Published on 28 Nov 2024

Navigating regulatory and policy challenges for AI enabled combination devices

in Regulatory Affairs

Snigdha Santra
Preet Kukreja
Kinshuk Saxena
Sanyam Gandhi
Om V. Singh

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1473350

6,235 views
12 citations

Perspective

Published on 12 Nov 2024

An approach to reduce inhaler errors using Donabedian's triad

in Regulatory Affairs

Dorothy May Isip Cruz
Manjush Karthika
Ashraf Alzaabi

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1494089

3,802 views
2 citations

Original Research

Published on 06 Aug 2024

Trends in the market for drug delivery devices categorized as combination drugs and medical devices and regulatory challenges for autoinjectors in Japan

in Regulatory Affairs

Makiko Mochizuki
Hideki Maeda

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1461460

3,435 views
1 citation

Review

Published on 10 Jul 2024

Ensuring safety and efficacy in combination products: regulatory challenges and best practices

in Regulatory Affairs

Deepak Kumar Gupta
Akhilesh Tiwari
Yashraj Yadav
Pranay Soni
Megha Joshi

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1377443

6,550 views
4 citations

Review

Published on 14 Jun 2024

Ethical considerations in the regulation and use of herbal medicines in the European Union

in Regulatory Affairs

Anthony Raphael Gatt
Patricia Vella Bonanno
Raymond Zammit

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1358956

11,144 views
21 citations

Original Research

Published on 05 Apr 2024

Risks and benefits associated with the primary functions of artificial intelligence powered autoinjectors

in Regulatory Affairs

Marlon Luca Machal

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1331058

2,940 views

Systematic Review

Published on 21 Mar 2024

Designing Chinese hospital emergency departments to leverage artificial intelligence—a systematic literature review on the challenges and opportunities

in Regulatory Affairs

Sijie Tan
Grant Mills

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1307625

7,921 views
3 citations

Editorial

Published on 04 Mar 2024

Editorial: Understanding the impact of lung ventilation heterogeneity

in Regulatory Affairs

Brooks Kuhn
Igor Barjaktarevic

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1332958

2,034 views

Original Research

Published on 22 Feb 2024

Implantation accuracy of novel polyimide stereotactic electroencephalographic depth electrodes—a human cadaveric study

in Regulatory Affairs

Aura Kullmann
Farida Akberali
Jaime J. Van Gompel
Robert A. McGovern
W. Richard Marsh
Debra Kridner
Camilo A. Diaz-Botia
Michael C. Park

Frontiers in Medical Technology

doi 10.3389/fmedt.2024.1320762

3,466 views
1 citation

Brief Research Report

Published on 24 Nov 2023

Framework for creating a qualified medical device development tool of autoinjectors

in Regulatory Affairs

Marlon Luca Machal

Frontiers in Medical Technology

doi 10.3389/fmedt.2023.1281403

3,844 views
2 citations